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    Summary
    EudraCT Number:2018-001312-30
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-001312-30
    A.3Full title of the trial
    SPRING - Seizure PRophylaxis IN Glioma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating the use of levetiracetam to prevent seizures after brain surgery.
    A.3.2Name or abbreviated title of the trial where available
    SPRING - Seizure PRophylaxis IN Glioma
    A.4.1Sponsor's protocol code number
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCommon Services Agency
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationScottish Clinical Trials Research Unit
    B.5.2Functional name of contact pointEve Macdonald Chisholm
    B.5.3 Address:
    B.5.3.1Street AddressSCTRU, PHI, NSS
    B.5.3.2Town/ city1 South Gyle Crescent
    B.5.3.3Post codeEH12 9EB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312757058
    B.5.5Fax number01312757512
    B.5.6E-mailnss.spring@nhs.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Keppra
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKeppra
    D.3.2Product code ucb 22059
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLevetiracetam
    D.3.9.1CAS number 102767-28-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Seizures in patients with suspected cerebral glioma
    E.1.1.1Medical condition in easily understood language
    Seizures in patients with suspected primary brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018338
    E.1.2Term Glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061030
    E.1.2Term Brain tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This aim of the study is to investigate whether use of levetiracetam before surgery will help to prevent patients with suspected brain tumours developing seizures after their surgery.

    The patients will have surgery planned and will have not experienced a seizure.

    We will give half of these patients current standard care (no anti-epileptic drug) and the other half will receive an anti epileptic drug called levetiracetam before surgery and for up to one year after to see if this drug will reduce their risk of having seizures. Using a drug in this manner is called prophylactic use.
    E.2.2Secondary objectives of the trial
    In patients with a suspected brain tumour, that have never had a seizure, does taking preventative (taken before any seizure) levetiracetam:
    • Delay the time for a patient to have their first seizure.
    • Delay the time for a patient to have their first tonic-clonic (or convulsive) seizure.
    • Have any affect on patients’ mood, personality, energy levels (tiredness) or memory.
    • Have any effect on how the severe the first seizure is if it happens.
    • Have an impact on the patients quality of life (wellbeing )
    • Have an impact on a patient’s survival without cancer relapse.
    • Have an impact on a patient’s survival.
    • Reduces costs to the NHS and personal social services (PSS) over the 12 months trial follow-up.

    In addition the study will investigate if taking preventative (taken before any seizure) levetiracetam is cost effective. The cost effectiveness will be measured by looking at cost change per Quality adjusted life year (QALY) over a 12 month period. A Quality adjusted life year is
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Patients with suspected cerebral glioma on MRI
    
2)Capable of giving informed consent
    
3)Patients must be ≥ 16 years old
    
4)Patients must have a Karnofsky performance status ≥70
    
5)Patients must be able to safely swallow pills
    6)Planned surgery for presumed glioma (biopsy or resection)
    E.4Principal exclusion criteria
    1)Pregnant
    2)History of any type of seizure for at least 10 years prior to randomisation 
3)Known Severe Chronic Kidney Disease (CKD4 - eGFR < 30ml/min)
    4)Concomitant methotrexate
    5)Concomitant AED (including use for other reasons (e.g. pain))
    6)Concomitant benzodiazepines
    7)Hypersensitivity to levetiracetam
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome is one year risk of first seizure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluated at clinic visits at 3, 6, 9 and 12 months.
    E.5.2Secondary end point(s)
    Time to first seizure
    Time to first tonic clonic seizure
    Mood, personality, fatigue and memory
    Severity of first seizure
    Quality of life
    Progression free survival
    Overall survival
    Costs to the NHS (National Health Service) and personal social services (PSS)
    cost-effectiveness
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluated at clinic visits at 3, 6, 9 and 12 months and through monthly telephone calls from a research nurse.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no anti-epileptic drug (Standard of Care)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 8
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 474
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 322
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state804
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If the patient's treating clinician feels that it is in the patients best interest to stay on levetiracetam after the trial medication is due to be stopped then they will discuss this with the patient and arrange for levetiracetam to be prescribed locally.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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